MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 100% stenosed, 55mm x 2.75mm target lesion was located in the severely tortuous and moderately calcified left anterior descending artery.A 2.5mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, the tip of the device and the delivery shaft of the balloon were fractured.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that shaft break occurred.The 100% stenosed, 55mm x 2.75mm target lesion was located in the severely tortuous and moderately calcified left anterior descending artery.A 2.5mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, the tip of the device and the delivery shaft of the balloon were fractured.The procedure was completed with another of same device.There were no patient coplications reported and the patient's status was stable.
Additional Manufacturer Narrative
The device was returned for analysis.The balloon was tightly folded with blood in the wire lumen (inner shaft).The tip, balloon, proximal weld, inner/outer shaft were microscopically and visually inspected.Inspection revealed numerous kinks in the hypotube.The device was not fractured (separated) and there was no damage to the tip.Inspection of the rest of the device found no other damage or defect.The reported fracture was not confirmed.

• Brand Name: QUANTUM MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8611709
• Report Number: 2134265-2019-05084
• Device Sequence Number: 13892353
• Product Code: LOX
• UDI-Device Identifier: 08714729392767
• UDI-Public: 08714729392767
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2021
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0023109601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 72